Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.

Completed · Phase 2

Conditions studied: Epilepsy

In brief

Initial study in children with epilepsy to evaluate the pharmacokinetics, safety, tolerability and preliminary efficacy of adjunctive treatment with brivaracetam, and to develop dosing adaptations for future studies.

Key facts

Study ID

NCT00422422

Run by

UCB Pharma

People needed

100

Starts

2011-07-01

Expected to finish

2013-03-01

Last updated by the study team

2018-07-11

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of epilepsy
• Subject having at least 1 seizure (any type) during the 3 weeks before first visit
• Stable dosing of 1-3 concomitant antiepileptic drugs

You may not qualify if…

• Pregnant or nursing females
• Concomitant use of Levetiracetam
• Epilepsy secondary to a Progressive cerebral disease/tumor or other neurodegenerative disease
• History of status epilepticus
• Clinically significant acute or chronic illness, underlying disease or medication condition
• History of suicide attempt

Where it is running

• 108 — Gulf Breeze, Florida, United States
• 110 — Miami, Florida, United States
• 103 — Wellington, Florida, United States
• 106 — Boston, Massachusetts, United States
• 101 — Saint Paul, Minnesota, United States
• 113 — Chesterfield, Missouri, United States
• 105 — Buffalo, New York, United States
• 104 — Rochester, New York, United States
• 107 — Cincinnati, Ohio, United States
• 114 — Pittsburgh, Pennsylvania, United States
• 109 — Nashville, Tennessee, United States
• 117 — Houston, Texas, United States
• 202 — Brussels, Belgium
• 203 — Brussels, Belgium
• 201 — Leuven, Belgium
• 502 — Hradec Králové, Czechia
• 504 — Ostrava Porubo, Czechia
• 501 — Prague, Czechia
• 602 — Aguascalientes, Mexico
• 611 — Chihuahua City, Mexico
• 609 — Ciuliacan, Mexico
• 603 — Guadalajara, Mexico
• 604 — Mexico City, Mexico
• 610 — Monterrey, Mexico
• 607 — San Luis Potosí City, Mexico

Full record on ClinicalTrials.gov

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